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FDA 510(k) Application Details - K052086
Device Classification Name
More FDA Info for this Device
510(K) Number
K052086
Device Name
ENCORE REVERSE SHOULDER PROSTHESIS HUMERAL STEM ADAPTER
Applicant
ENCORE MEDICAL, INC.
9800 METRIC BLVD.
AUSTIN, TX 78758 US
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Contact
CHRISTIE SHUMAKER
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Regulation Number
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Classification Product Code
PHX
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Date Received
08/02/2005
Decision Date
08/31/2005
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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